Dynamic Leaflet Support System for Enhanced Cardiac Valve Function
Legal Citation
Summary of the Inventive Concept
A next-generation leaflet support system that dynamically adapts to changes in the heart valve annulus, promoting optimal blood flow and reducing the risk of regurgitation.
Background and Problem Solved
The original patent, 'Leaflet Support,' addressed the issue of dilation of the annulus of a heart valve, which prevents the valve leaflets from fully coapting. However, the original design has limitations in terms of adaptability and optimal blood flow. The new inventive concept overcomes these limitations by introducing a dynamic, self-adjusting frame that conforms to changes in the annulus, ensuring optimal blood flow and reducing the risk of regurgitation.
Detailed Description of the Inventive Concept
The Dynamic Leaflet Support System comprises a leaflet support with a dynamic, self-adjusting frame that adapts to changes in the annulus of a heart valve. The frame defines an array of cells with varying porosity to facilitate optimal blood flow. The system can be deployed using a shape-memory alloy frame that conforms to the annulus of the heart valve, and can be configured to dynamically adjust to changes in the annulus over time. Additionally, the system can integrate sensors to track changes in valve performance and provide personalized recommendations for valve adjustment and maintenance. The system can also be designed with a nanofiber-based frame that promotes tissue ingrowth and integration, and defines a pattern of micro-perforations to enhance blood flow and reduce turbulence. Furthermore, the system can be developed as a biohybrid leaflet support that integrates living cells and biomaterials, mimicking the native heart valve anatomy and promoting optimal hemodynamics.
Novelty and Inventive Step
The new claims introduce a paradigm shift in leaflet support design by incorporating dynamic, self-adjusting frames that adapt to changes in the annulus, and integrating sensors and data analytics for real-time monitoring and personalized recommendations. These features are novel and non-obvious compared to the original patent, which did not contemplate such advanced functionality.
Alternative Embodiments and Variations
Alternative embodiments of the Dynamic Leaflet Support System could include the use of different materials, such as biodegradable polymers or metallic alloys, or variations in the frame design, such as a spiral or lattice structure. The system could also be adapted for use in other cardiac valve applications, such as pulmonary or tricuspid valves.
Potential Commercial Applications and Market
The Dynamic Leaflet Support System has significant commercial potential in the cardiac valve repair market, which is projected to grow significantly in the coming years. The system's ability to adapt to changes in the annulus and provide real-time monitoring and personalized recommendations makes it an attractive solution for patients and clinicians alike.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61F2/2448 |
| A | A61 | A61F2/2466 |
| A | A61 | A61F2230/0006 |
| A | A61 | A61F2230/0008 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Cardiac medical devices, specifically heart valve repair and support technologies, requiring advanced biomedical engineering, materials science, and interventional cardiology expertise
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or interventional cardiologist with advanced degrees, experience in medical device design, understanding of cardiac anatomy, biomaterials, and minimally invasive surgical techniques
Obviousness Rationale
A PHOSITA would recognize that the dynamic, sensor-integrated leaflet support system represents predictable technological progression from the source patent's foundational cardiac valve support design. The core structural elements remain consistent, with incremental improvements in adaptability, monitoring, and tissue integration being logical extensions of existing cardiac implant technologies. These variations represent standard engineering problem-solving approaches to enhancing medical device functionality.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,417 |
|---|---|
| Title | Leaflet support |
| Assignee(s) | TRILIO MEDICAL LTD. |